Marketing authorisations—regulatory procedures for approval of medicinal products
Marketing authorisations—regulatory procedures for approval of medicinal products

The following Life Sciences practice note provides comprehensive and up to date legal information covering:

  • Marketing authorisations—regulatory procedures for approval of medicinal products
  • Regulatory framework
  • Legislation
  • Guidelines
  • Impact of Brexit on marketing authorisations
  • EU centralised authorisation procedure
  • Scope of the centralised procedure
  • Centralised procedure—pre-submission phase
  • Centralised procedure—phase 1—EMA evaluation procedure
  • Centralised procedure—phase 2—Commission decision-making process
  • More...

On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a Member State for many purposes. As a third country, the UK can no longer participate in the EU’s political institutions, agencies, offices, bodies (except to the limited extent agreed), but it continues to be subject to EU law and must submit to the continuing jurisdiction of the Court of Justice of the EU in accordance with the transitional arrangements in Part 4 of the Withdrawal Agreement. For further reading, see: Brexit—Life Sciences and News Analysis: Brexit Bulletin—key updates, research tips and resources.

No medicinal product may be placed on the market without having first obtained an approval known as a marketing authorisation (MA). The MA sets out the medical conditions (known as indications), patient population and dosage for which the product is authorised as well as any conditions imposed on the MA holder (MAH). The approval of medicinal products is regulated by Directive 2001/83/EC on the Community Code relating to medicinal products for human use (Pharmaceutical Code) which is implemented in the UK by the Human Medicines Regulations 2012, SI 2012/1916 (HMRs).

There are several different routes available to obtain an MA for medicinal products. These are:

  1. the EU centralised procedure

  2. the mutual recognition procedure

  3. the decentralised

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